Average salary: €24,461 /yearly
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- ...Category: Professional All Job Posting Locations: Cork Cork Ireland Job Description: Duties & Responsibilities: NC CAPA Quality System Investigation Process: Supply Chain Implementation Support efficient and effective investigation training/...Suggested
- A leading medical device company located in County Cork is seeking a Senior Quality Engineer to contribute to the quality operations team. This position involves overseeing quality-related activities and mentoring team members while ensuring high-quality standards. The ideal...Suggested
Stryker Group
Cork2 days ago - ...Article Inspections, ensure adherence to regulatory requirements mainly ISO, support investigation and documentation of Customer complaints/CAPAs. Work collaboratively with the IS&T department and Engineering on aligning the physical processes with IM’s Service Platforms (i.e....SuggestedHybrid workLocal areaRemote work
Iron Mountain
Cork5 days ago - ...revision management. Complete applicable QMS documentation as required by the regulatory and change management process. May own NCs/CAPAs as needed. May assist with regulatory audits. Participate and own improvement projects on the team. What you will need:...SuggestedPermanent employmentFull timeHybrid work
- ...monitor response time. Review and approve quality actions including Non-Conformances (NC) and/or Corrective Action Preventative Action (CAPA) Assist project team in determining and socializing project value and end user benefit Provide updates on status and blockers...SuggestedFull timeFor contractorsLocal area
- ...Support and provide regulatory input for pharmaceutical quality system deliverables such as batch variation summaries, customer complaints, CAPA, deviations, NCMR, etc. for the manufacturing site(s). Prepare and submit OPDP, NDA and IND submissions and annual reports using...SuggestedPermanent employmentLocal areaWorldwideFlexible hours
- ...maintain compliance in complex areas (such as ever-evolving regulatory requirements worldwide).* Support audits, non-conformances and CAPAs as needed.* Lead small- scale Packaging projects to drive changes across the packaging team.* Mentor or supervise technical staff as needed...SuggestedFixed term contractWorldwide
Stryker Corporation
Cork1 day ago - ...closely with operations and the business functions to ensure quality performance of product and processes. Oversee and approve NC & CAPA, activist and mentor in problem solving and root causing activities. Lead and participate in the development and improvement of the...Suggested
Stryker Group
Cork2 days ago - ...on key performance metrics (yield, downtime, cost per unit, etc.) and drive improvements based on findings.* Support and lead **audits, CAPA closure, and documentation updates** to ensure compliance with ISO 13485 and FDA QSR standards.* Train and mentor technicians and...SuggestedPermanent employmentContract workHybrid work
Stryker Corporation
Cork4 days ago - ...patient risk. Supports the planning pipeline of quality improvement activities including initiatives to increase product quality NCR & CAPA resolution reduce cost decrease in-efficiencies and improve risk management Oversight and responsibility to ensure site maintains...SuggestedFull timeLocal area
- ...of disability. Required Skills: Preferred Skills: Analytical Reasoning Communication Corrective and Preventive Action (CAPA) Industry Analysis Information Security Auditing Information Security Management System (ISMS) Information Technology (IT) Security...SuggestedFull time
- ...systems. Work proactively with operations and engineeringteams to support investigations, issue resolution, and timely closure of NCsand CAPAs. Stay current with emerging automation technologiesand contribute to long-term automation strategy. Requirements...SuggestedLong term contractFlexible hours
Simotechnology
Cork3 days ago - ...Projects and Programs across the site. Oversee quality planning, risk assessments, and approval of key documentation (SOPs, protocols, CAPAs, etc.). Ensure compliance and inspection readiness for regulatory agencies (HPRA/FDA) and internal standards. Analyse quality...Suggested
Allergan
Cork2 days ago - ...Verification (CPV). This role ensures compliance with regulatory standards drives documentation excellence and supports quality investigations CAPAs and change control processes. The position plays a key role in maintaining data integrity and enabling continuous improvement across...SuggestedFull timeRelocation package
- ...consultative and collaborative support on quality related issues; Lead & support investigation root cause and resolution ensuring appropriate CAPA actions implemented to prevent recurrence where relevant; Author track manage change review/approve/authorise relevant documentation...SuggestedFull timeRelocation packageWorldwide
- ...-related deviations, non‑conformances, and sterility failures. Perform root cause analysis, define corrective and preventive actions (CAPAs), and ensure timely closure of quality events at the Shanbally site and within Global Operations. Data Analysis & Risk Mitigation:...Worldwide
BIOMARIN
Cork1 day ago - ...a review and approval of all vendor supplied documentation. Author documents that ensure cGMP compliance, such as investigations, CAPAs, reports and forms. Perform other related duties or projects as assigned. Experience: Bachelor’s Degree required in a scientific...Contract work
QA Resources
Cork1 day ago - ...new products. ~ You will lead design validation efforts to ensure new products meet all customer user needs. ~ You may lead NC & CAPA which require expertise in problem solving and root cause analysis. What you need: ~ Bachelors in a science engineering or...Permanent employmentFull timeHybrid work
- ...alignment develop a quality planning pipeline of quality improvement activities including initiatives to increase product quality NCR & CAPA resolution reduce cost decrease in-efficiencies and improve risk management. Has a track record of building high performing teams...Full timeHybrid work
- ...Test Certificates ensuring data integrity and technical accuracy. Undertake root cause analysis of failures implementing effective CAPA actions. Conduct internal quality audits support regulatory and customer audits and ensure timely closure Lead coach and mentor departmental...Long term contractFull timeContract workTemporary workRemote workWorking Monday to Friday
- ...External Audit/Inspections preparation and management processes for the Site (including follow up on audit action completion associated CAPAs and NC Quality approval). Participate in Site risk assessments. Execute site and quality driven improvement projects...
- ...execute the annual GMP refresher and GMP induction program across GSIUC May conduct or serve as a lead/coordinator of deviations and CAPA recommendations. Performs a wide variety of activities to ensure compliance with applicable regulatory requirements. These may...Full timeFor contractorsLocal area
- ...Demonstrated experience with trending and analysis reporting Demonstrated knowledge of adverse event reporting complaint investigation CAPA and corrective action processes Demonstrated leadership skills Demonstrated process improvement and management skills...Full time
- ...qualification and validation phases. Oversee contractor/vendor activities related to CQV execution. Manage deviations, change controls, and CAPAs arising from CQV execution. Interface with project engineering, quality, manufacturing, and automation teams to drive project...Contract workFor contractors
BioTalent Ltd
Cork5 days ago - ...objectives using teamwork Lead continuous improvement initiatives and projects for the line and/or value streamLead in the resolution of NC & CAPAs as required and ensure effective compliance with Quality Management System (QMS).As a competent Operations Associate SME trains and...Full time
- ..., including administrative tasks. Lead computer system validation/assurance efforts in line with regulatory requirements. Manage CAPA, non-conformance investigations, and customer complaint processes. Direct risk management and usability engineering activities, including...Permanent employmentFull timeContract workImmediate start
- ...manufacturing process to meet its stated purpose. Initiate deviation records and ensure on-time closure of open records with appropriate CAPAs and effectiveness checks in place. Demonstrate a structured approach to problem solving and investigation. Support regulatory...Contract workWorldwideShift workNight shiftWeekend work
Eli Lilly and Company
Cork4 days ago - ...shutdowns. Support investigations into equipment failures and contribute to root cause analysis activities. Complete deviations, CAPAs and change controls as required. Develop and maintain standard job plans, maintenance procedures and scheduling processes. Build...
Uniting Holding
Cork5 days ago - ...Packaging Development Engineering Material Operations & Packaging technicians & BPSs to support escalation resolution and implement effective CAPAs. SUPERVISOR RESPONSIBILITY The Packaging Operations Team Lead of a given functional area will typically have 8-15 direct...Full timeWorking Monday to FridayFlexible hoursShift workRotating shift
- ...SOPs and Boston Scientifics Product Life Cycle Process (PLCP). Apply critical thinking and engineering analysis to solve problems. CAPAs VIPs and regulatory requirement changes. Analytical and problem-solving abilities. Analyses draws conclusions and makes appropriate...Full timeWorldwide
